Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

This study has been completed.
Sponsor:
Collaborator:
University of Tehran
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01120925
First received: May 8, 2010
Last updated: April 24, 2014
Last verified: May 2010
  Purpose

Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it`s crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.


Condition Intervention Phase
Liver Cirrhosis
Biological: MNC
Biological: CD133
Biological: Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Liver function test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Meld score, Child score


Secondary Outcome Measures:
  • Cirrhosis Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MNC
Bone marrow derived MNC
Biological: MNC
2-3 X 109 cells in 20ML suspension IPV in 4 min
Experimental: CD133
CD133 derived from Bone marrow
Biological: CD133
5-15 X 106 cells in 20ML suspension IPV
Placebo Comparator: Control
Normal saline with 5% Human Serum Albumin
Biological: Control
Injection of 20 ml Normal saline via IPV

Detailed Description:

BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16-65 Years cirrhotic patient
  • Approved cirrhosis by elastografy ,biopsy, sonography
  • Serum ALT 1/5 times more than normal
  • MELD score 12 or Child score B or C

Exclusion Criteria:

  • Portal vein thrombosis
  • Hepatic encephalopathy, score 3&4
  • ALT & AST 3times more than normal
  • Serum Cr more than 1/5mg/dL
  • (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
  • Hepatocel carcinoma
  • Primary sclerosing cholangitis (PSC)
  • Esophageal varices grade 4
  • Addiction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120925

Locations
Iran, Islamic Republic of
Gastroenterology and hepatic disease research center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Royan Institute
University of Tehran
Investigators
Study Chair: Hamid Gourabi, PhD Royan Institute
Study Chair: Reza Malekzadeh, MD Gastroenterology and hepatic disease research center
Principal Investigator: Hossein Baharvand, PhD Royan Institute
Principal Investigator: Mohammad Bagheri, MD Gastroenterology and hepatic disease research center
Study Director: Massoud Vosough, MD Royan Institute
Principal Investigator: Nasser Aghdami, MD., PhD Royan Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01120925     History of Changes
Other Study ID Numbers: Royan-Liver-002
Study First Received: May 8, 2010
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Cirrhotic
Stem Cells
Bone marrow stem cells
Decompensate Cirrhotic Patients

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014